BEUDAMED
    Product Code: LZC FDA class 1 21 CFR 880.6250

    Medical Glove, Specialty

    General Hospital

    The Specialty Medical Glove (product code LZC) is a disposable examination or surgical glove that may or may not contain residual powder and is worn on the hand or finger(s) for medical purposes to prevent contamination, with specialty claims such as chemotherapy drug handling or other specific applications beyond standard examination use. Regulated under 21 CFR 880.6250 and classified as a Class 1 device, it falls under the General Hospital specialty and is eligible for third-party review. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    78
    FEI Numbers
    297
    Registration Numbers
    297
    Unique Applicants
    62
    Years Active
    36

    Basic Information

    Product Code
    LZC
    Device Class
    FDA class 1
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Review Panel
    HO
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    A disposable medical glove (examination or surgeon’s) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition, these gloves may have specialty claims such as chemotherapy, etc.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 78 510(k) clearances via K numbers.

    K Number Device Name
    K243959 Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs
    K221157 JR Medic
    K222449 Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)
    K220545 Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs
    K220491 Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs
    K220353 Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs
    K213910 Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs
    K213325 Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs
    K213076 AspenMed+
    K212639 Disposable Medical Nitrile Examination Gloves (Non sterile)
    K212827 Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs
    K200633 Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove
    K201390 Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)
    K193555 Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate
    K191230 Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves
    K183562 Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs
    K182382 Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink
    K183149 Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim
    K190159 Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove
    K182383 Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue
    K183132 Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
    K181130 Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs
    K173766 PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs
    K180646 Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
    K180476 Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
    K172864 Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
    K173942 Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
    K172642 Orange Non Sterile Powder Free Nitrile Examination Gloves
    K172525 Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
    K162858 NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST
    K162186 BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM
    K163017 Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
    K163146 POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs
    K160709 HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves
    K151390 Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs
    K152222 NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs
    K141982 DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
    K121811 POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES
    K121926 BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM
    K120336 NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U
    K102189 POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM
    K102790 POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG
    K101822 NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
    K101436 PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)
    K101596 KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER-
    K093500 POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE
    K091643 POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
    K083410 POWDER FREE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL CLAIM
    K083408 POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
    K083409 POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL
    K083305 POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM
    K081971 BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES
    K081089 KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM
    K072197 POWDER-FREE LATEX EXAMINATION GLOVES - 18 MILS AT FINGER, BLUE COLOR; 9 AND 10 MILS AT FINGER, NATURAL COLOR
    K062764 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED
    K042805 POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE
    K033789 LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING
    K032444 NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY
    K032374 POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED
    K010211 STERILE NITRILE POWDER-FREE EXAMINATION GLOVES
    K990677 ABSOGEL CHEMOTHERAPHY GLOVES
    K992162 SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM
    K982832 PROGUARD, RR-1, RR-2
    K970135 NITRILE GLOVES
    K945577 GUARDIAN II GLOVE
    K942313 GUARDIAN GLOVE
    K920620 FLUORO-SHIELD RADIATION REDUCTION GLOVES
    K905527 NEEDLESTICK PROTECTIVE GLOVE
    K905177 STAT(TM) GLOVE
    K903142 AUKUFLEX(TM) RADIATION RESISTANT GLOVES
    K896759 PB PLUS LEAD LATEX GLOVES
    K895195 CHEMO-TOUCH
    K895781 ANSELL E.P. EXTRA-PROTECTION EXAMINATION GLOVES
    K893093 FLOUROSHIELD RADIATION REDUCTION GLOVE
    K896076 L(3), LYSNIG LEAD LATEX RADIATION GLOVE(R)
    K891315 ATTENUATING SURGICAL GLOVE
    K891968 ESP RADIATION REDUCTION EXAMINATION GLOVES
    K882437 L3 (LEAD LATEX LYSNIG GLOVES)

    FEI Numbers

    This FDA classification entry is associated with 297 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 297 registration numbers. Click on an entry to view related FDA registrations.